Accelerating Biosimilar & Biobetter
Drug Development

A new era of biologic drugs has begun. Biosimilars and biobetters are approved follow-on versions of innovator biologics that provide opportunities for reducing the cost of treatment without compromising quality.

The development pathway of a biosimilar or a biobetter is different from that of novel biotherapeutics, requiring increased bioanalytical testing. Requirements for comparability, efficacy, and potency testing often demand a complex set of bioassays and/or cell-based assays for biosimilars and biobetters. Developers of these follow-on biologics have found this need for cell-based assays to be particularly challenging.